The Food & Drug Administration’s (FDA) Hazard Analysis and Critical Control Points (HACCP) principles and practices started as a joint project between NASA and Pillsbury in the 1960s. The goal of HACCP was to ensure safe food for NASA’s astronaut program. Since then, the HACCP regulation has expanded to other aspects of food safety – including seafood.
HACCP seafood regulations were put in place over twenty years ago, requiring the processors to implement controls and methods to monitor and ensure food’s safe handling. A HACCP plan identifies food safety-related procedures that must be followed to manage and minimize food safety hazards. Seafood HACCP plans are required for all aspects of the product’s production, from processing raw material through finished product storage
Because imported seafood is popular (currently, it’s between 60 – 80 percent of all fish consumed in America), Seafood HACCP regulations continue to create challenges for foreign processors, whether drafting, implementing, compliance, or enforcement.
Drafting a HACCP plan is often the most straightforward part of the process; FDA lays out the required steps and information on its website:
- Conduct a hazard analysis (Principle 1)
- Determine critical control points (CCPs) (Principle 2)
- Establish critical limits (Principle 3)
- Establish monitoring procedures (Principle 4)
- Establish corrective actions (Principle 5)
- Establish verification procedures (Principle 6)
- Establish record-keeping and documentation procedures (Principle 7)
The program’s implementation is where the rubber meets the road; if inspected by FDA, a seafood product may be deemed adulterated if the HACCP plan is not followed explicitly.
When FDA conducts a seafood inspection, they begin with a walk-through of the facility to understand the processing flow from receipt of the raw materials through finished product storage. The investigator conducts their own hazard analysis, identifying potential hazards and where controls need to be in place; then creates their own HACCP plan, which is compared to the processor’s HACCP plan. Questions will be asked if there are notable differences, allowing the processor to explain its HACCP plan.
Finally, FDA observes the processing and reviews the records to determine the accuracy of the HACCP plan’s implementation.
Simply put, you are out of compliance if implementation does not match the written HACCP plan.
Seafood HACCP and Import Alerts
HACCP plans, written corrective actions, and the monitoring of records of foreign manufacturers, are reviewed by FDA regularly as a part of the import alert process. FDA currently has at least twenty-eight seafood-related import alerts in place; removal from an import alert often requires supporting documentation of compliance with applicable regulations and a minimum of 5 consecutive “clean” released shipments. Expectations are very high when reviewing a HACCP plan and supporting documentation. Since the implementation of FDA’s Food Safety Modernization Act (FSMA), the review process has become even more difficult for foreign suppliers.
Some common errors include:
- Critical limits (Maximum or minimum values) identified on a HACCP plan not being followed based on monitoring records,
- Procedures that outline receiving aquacultured fish not being followed,
- Corrective actions not being followed, including failure to discontinue current suppliers if raw material is rejected, and
Lack of supporting documentation for root-cause analysis of a violation that caused the Food/Foreign Supplier to be added to an Import Alert.
These consequences can be easily avoided by extensive reviews prior to the petition submission to FDA. The attorneys and regulatory specialists at FDAImports are experienced in reviewing your HACCP program and supporting documentation and can help develop petitions for removal from import alert “red lists.” Please feel free to contact us or call us at 410.220.2800.
This blog is provided for informational and educational purposes only and does not constitute legal advice, and is not intended to form an attorney-client relationship. Please contact your regular FDAImports representative for additional information.
